The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer

NCT01332773 | Unknown Phase 3

• 1 other identifier: NNR-7
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

To show whether the artery first approach leads to equal or less rate of positive resection margins in pancreatic head cancer than the standard technique (ppWhipple only with standard Kocher's manoeuvre)

Conditions

Pancreatic Head Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of R1 resections

  positive resection margins as described by the pathologists of the University of Heidelberg

  up to 1.5 years

Secondary Outcomes (1)

• Exploratory analyses

  up to 1.5 years

Study Arms (2)

Artery first group

EXPERIMENTAL

The basic principle of the "artery first" approach is the early identification of the SMA at its origin at the aorta with the further resection then being guided by its anatomic course. The dissection is carried cephalad along the aorta until the origin of the SMA is reached. The posterior and right aspect of the SMA is then dissected over a few centimeters. On the right side of the SMA a replaced or accessory right hepatic artery, if present, will be identified and preserved. This maneuver should be done, if infiltration of the SMA is suspected as the procedure can be terminated at this point. Once the situation at the SMA is assessed and resectability is confirmed resection will be done.

Procedure: Artery first procedure

Conventional Group

ACTIVE COMPARATOR

A wide Kocher manoeuver is performed to fully mobilize the duodenum and the head of the pancreas. The colonic mesentery on the right side is separated from the anterior surface of the duodenum and the head of the pancreas. The size of the tumor and its relation to the superior mesenteric artery, the celiac trunk, the mesentery, the portal vein, and the superior mesenteric vein is assessed. If resectability is given a Kausch-Whipple's resection is performed.

Procedure: No artery first procedure

Interventions

Artery first procedure PROCEDURE

early identification of SMA to evaluate infiltration

Artery first group

No artery first procedure PROCEDURE

conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma

Conventional Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pancreatic head cancer (diagnosis by clinical, laboratory and radiological evaluation)
• Patients scheduled for curative resection
• No evidence of distant metastases
• Age equal or greater than 18 years
• Informed consent

You may not qualify if:

• Expected lack of compliance
• Impaired mental state or language problems
• patient having had neoadjuvant radiochemotherapy

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Department of General, Visceral and Transplantation Surgery, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Central Study Contacts

Nuh N. Rahbari, MD

CONTACT

+496221; nuh.rahbari@med.uni-heidelberg.de

Heike Elbers

CONTACT

+496221; heike.elbers@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: March 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 19, 2011

Record last verified: 2009-12

Locations

DE (1)